Combination of SGLT2 inhibitor and DPP-4 inhibitor as add-on therapy in subjects with type 2 diabetes inadequately controlled on insulin combined with metformin + DPP-4 inhibitor or metformin + SGLT2 inhibitor or metformin : open-label, multicenter trial

Korea University Anam Hospital0 sites102 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 7, 2023

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Sponsor

•(1\) Diagnosed with type 2 diabetes (according to the American diabetes association standard) by a blood test
•(2\) Patients using basal insulin and metformin at least 1,000 mg / day with stable volume for at least 8 weeks before Visit 1 (Screening)
•(3\) Hemoglobin A1c (HbA1c) equal to (\=) 7\.5 percent (%) to 12%
•(4\) 18 Years to 74 Years (Adult)
•(5\) Body mass index of 20 through 35 kilogram per meter square (kg/m^2\)
•(6\) Estimated glomerular filtration rate (eGFR) of at least 45 milliliter/minute (mL/min)/1\.73 meter square (m^2\)
•(7\) Basal C\-peptide level or more 1\.0ng/ml

•(1\) Patient with hypersensitivity reaction to the drug in this study or a drug containing a homologous system (eg, a history of hypersensitivity to SGLT2i or DPP4i)
•(2\) Have the following medical history or history of surgery / treatment
•\-Type 1 diabetes
•\-Diabetic ketone acidosis at screening
•\-Diabetic coma or pre\-coma at screening
•\-Experience cardiovascular events (acute coronary artery disease, cerebral infarction, transient ischemic attack) within 3 months of screening criteria
•\-Patients diagnosed with solid or blood cancers and are or are planning to be treated
•\-Past history of acute pancreatitis
•\-Urinary tract or genital infections within the last year
•\-Suspected alcohol abuse